Apparatus and method for suspending a uterus

ABSTRACT

An inter-vaginal device for performing a uterine suspension includes a rigid body for manipulating the uterus and implanting a suspension member, such as a mesh, for securing the uterus to an anchoring site (e.g., into a pelvic muscle or ligament). In one embodiment, a method includes inserting at least a portion of a uterine suspension member through an anterior or posterior vaginal incision. An end of the suspension member is anchored to a selected portion of a pelvic tissue. At least a portion of the suspension member is attached to a vaginal apex. A uterine manipulator is advanced in a direction toward the selected portion of the pelvic tissue such that at least a portion of a uterus is moved upward.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of, and claims priority to, U.S.patent application Ser. No. 11/535,901, filed on Sep. 27, 2006, entitled“APPARATUS AND METHOD FOR SUSPENDING A UTERUS,” which, in turn, claimspriority to U.S. Provisional Application No. 60/721,366, filed on Sep.28, 2005, entitled “APPARATUS AND METHOD FOR SUSPENDING A UTERUS,” bothof which are incorporated by reference herein in their entirety.

BACKGROUND

The present invention relates generally to the field of medical devices,and in particular to an apparatus and method for suspending a uterus ofa human or animal subject.

Many women with uterine prolapse would like for their condition to besurgically corrected, but avoid or delay undergoing an operation becausethey wish to avoid hysterectomy. The potential reasons for avoidinghysterectomy vary widely including plans for future childbearing,concern about the invasiveness of the procedure or the difficulty of therecuperation, or fear of diminished sexual function. Some women aresimply reluctant to “give up” this part of their body so closelyassociated with their reproductive health, childbearing, and femininity.

Uterine prolapse can be effectively treated without hysterectomy, withlow morbidity and high rates of patient satisfaction. A properlyperformed uterine suspension surgery often results in a significantlybetter anatomic outcome than hysterectomy. Yet, many hysterectomyprocedures are performed for pelvic prolapse. One reason why mostpatients remain unaware of the uterine-sparing option is because withthe exception of a few dedicated sub-specialists, most surgeons receiveno training in these techniques. [n addition, known techniques andequipment can be difficult and require involved specialized trainingthat many general practitioners have not undertaken.

Thus a need exists for an improved apparatus and method for providing aminimally invasive hysteropexy that can be incorporated into mainstreamgynecologic practice.

SUMMARY OF THE INVENTION

An apparatus, method and kit for performing a uterine suspensionprocedure are disclosed herein. In one embodiment, an inter-vaginaldevice for performing a uterine suspension includes a rigid body formanipulating the uterus and implanting a suspension member, such as amesh, for securing the uterus to an anchoring site (e.g., into a pelvicmuscle or ligament). In another embodiment, a method includes insertingat least a portion of a uterine suspension member through an anterior orposterior vaginal incision. An end of the suspension member is anchoredto a selected portion of a pelvic tissue with anchoring methods that mayinclude tying off with sutures, or directly affixing the suspensionmember to the pelvic tissue with, for example, self-affixing mesh arms.At least a portion of the suspension member can be attached to a vaginalapex or adjacent to the vaginal apex to further facilitate scarring. Auterine manipulator can be advanced in a direction toward the selectedportion of the pelvic tissue such that at least a portion of a uterus ismoved upward.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of various components that can beused in a method according to an embodiment of the invention.

FIG. 2 is a side perspective view of a device for performing a uterinesuspension and a uterine suspension member according to an embodiment ofthe invention.

FIG. 3 is a front pictorial representation of a placement of asuspension member around a uterus using the device of FIG. 2.

FIG. 4 is a flowchart illustrating a method according to an embodimentof the invention.

FIG. 5 is a flowchart illustrating a method according to anotherembodiment of the invention.

DETAILED DESCRIPTION

The invention may be understood more readily by reference to thefollowing detailed description of the invention taken in connection withthe accompanying drawing figures, which form a part of this disclosure.It is to be understood that this invention is not limited to thespecific devices, methods, conditions or parameters described and/orshown herein, and that the terminology used herein is for the purpose ofdescribing particular embodiments by way of example only and is notintended to be limiting of the claimed invention. Also, as used in thespecification including the appended claims, the singular forms “a,”“an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment.

In some embodiments, the invention includes a device for performing auterine suspension comprising a substantially rigid body having a handleat a distal end thereof; a lumen through the substantially rigid bodyfor housing sutures of a suspension member; and a uterine manipulator ata proximal end thereof. The uterine manipulator can further include aprong for insertion into the uterus; a tenaculum clip for securing theuterine manipulator to the cervix; and a pair of wings for aiding insecuring the suspension member to the vagina. Optionally, the uterinesuspension device can be included in a kit, along with a mesh or graftfor a cystocele and/or a rectocele augmentation.

In another embodiment the invention includes a method of performing auterine suspension. The method can include the steps of making ananterior or posterior vaginal incision; palpating ischial spinesbilaterally; inserting the suspension member through the vaginalincision; placing suspension sutures of the suspension member or aportion of the suspension member (e.g., self-affixing tanged mesh) intoa sacrospinous or iliococcygeus anchoring site; inserting the uterinemanipulator through the cervix and securing it thereto; fastening thesuspension member to the corners of the vaginal apex or placing thesuspension member adjacent to the vaginal apex; applying gentle tractionon the sutures or the self-affixing mesh; advancing the uterinemanipulator to the anchoring site; removing the device; tying thesutures or adjusting the self-affixing mesh to the appropriate tension;and closing the vaginal incision.

In still another embodiment, the invention includes a suspension member,the suspension member includes at least one suture having an anchoringmember at a first end and a free end for manipulation by a practitioner,wherein the suture is woven through the suspension member for providingaccordion-type folds. In some embodiments, the suspension member isconstructed of a self-affixing mesh material requiring passage of mesharms rather than sutures through the pelvic tissue/anchoring site.

Advantageously, the device of the invention will introduce a minimallyinvasive, uterinesparing prolapse surgery that can be incorporated intomainstream gynecologic practice. The device can provide an effective,simple and reproducible uterine suspension technique for generalgynecologic surgeons. The procedures described herein have the potentialto attract countless women with uterine prolapse who would otherwisehave avoided an operation, and increase the market of women choosing thedescribed surgery for treatment of their prolapsed condition.

These and other aspects, features and advantages of the invention willbe understood with reference to the drawing figures and detaileddescription herein, and will be realized by means of the variouselements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the brief description of the drawings and detaileddescription of the invention are exemplary and explanatory of someembodiments of the invention, and are not restrictive of the invention,as claimed.

FIG. 1 is a schematic illustration of various components that can beused in a uterine suspension procedure to treat, for example, a uterineprolapse. A suspension device 110 can include a body 112 having auterine manipulator device 118 disposed at a proximal end of the body112. The suspension device can be, for example. a suspension device 10described in more detail with reference to FIG. 2. In some embodiments,the body 112 is substantially rigid and defines a lumen (not shown inFIG. I) extending between a proximal end and a distal end of the body112. The uterine manipulator device 118 can include, for example, aprong 134 configured to be inserted through a cervix, and a clip 136,such as a tenaculum clip, with a sharp point configured to secure theuterine manipulator device 118 to the cervix during a uterine suspensionprocedure, as will be described in more detail below with reference tothe uterine manipulator 18.

The suspension device 110 can be used to help secure a uterinesuspension member 120 within a pelvic region P of a patient. Asuspension member 120 can be formed, for example, with a mesh materialand configured to be anchored on one end to a pelvic tissue T1 such as asacrospinous ligament or a levator muscle, such as the iliococcygeusmuscle, and on another end to a pelvic tissue T2 disposed on an oppositeside of the uterus of the patient. Another portion of the suspensionmember 120 can be configured to be attached to a vaginal apex V of thepatient. An example embodiment of a suspension member 20 is described inmore detail below with reference to FIG. 2. An anchoring member 144 thatincludes a pair of winged portions (not shown in FIG. 1) can bereleasably coupled to the uterine manipulator 118 of the suspensiondevice 110 and inserted into a vagina of the patient using thesuspension device 110. An example embodiment of an anchoring member 44is described below with reference to FIG. 2. The anchoring member 144can be released from the suspension device 120 and used to help securethe suspension member 120 within the pelvic region P of the patient. Thesuspension device 110 can also be used to move or manipulate the uterusduring a uterine suspension procedure to place the uterus into a correctanatomical position.

With reference now to FIG. 2, an inter-vaginal uterine suspension device10 for performing a vaginal hysteropexy is shown by way of an exampleembodiment. The uterine suspension device 10 includes a substantiallyrigid body 12 having a shaft 14 with a handle 16 at its distal end and auterine manipulator portion 18 at its proximal end. Preferably, thehandle 16 is an ergonomic handle, and those skilled in the art willunderstand that various handles can be employed without deviating fromthe scope of the present invention.

The substantially rigid body 12 is used to implant a suspension member20 around the uterus so as to secure the uterus to a muscle or ligamentin the deep pelvic area. The body 12 can be constructed of an inert andbiocompatible material such as, for example, a metal such as titanium orstainless steel or a plastic, although those skilled in the art willunderstand that various materials can be employed without deviating fromthe scope of the present invention. The rigid body 12 can be reusable orit can be disposable. If the body is reusable, then the materials ofconstruction are preferably autoclavable or otherwise capable ofsterilization.

The suspension member 20 is configured generally in the shape of a “U”having a pair of arms 22 and 24. The suspension member 20 can be formed,for example, of polypropylene or prolene mesh, although those skilled inthe art will understand that various other biocompatible andbiologically inert materials can be used as well for the suspensionmember 20. Additionally, the suspension member 20 may not be a <<mesh”but instead be a band of an inert and biologically compatible material.

At least one, and preferably two tensioning sutures 26 and 28 are woveninto the suspension member 20 for providing a suspension member with anaccordion-type design (or accordion-type folds). A first anchor 30 islocated at the proximal end of the suture 26, and a second anchor 32 islocated at the proximal end of the suture 28. The anchors 30 and 32anchor or attach the sutures 26 and 28 to an anchoring site, which istypically a pelvic muscle or ligament. The distal ends of the pair ofsutures 26 and 28 are woven into the suspension member 20 and passthrough a lumen 29 through the shaft 14 and out of the body 12 of thedevice 10 near the handle 16 so that the practitioner can manipulate thesutures with one hand while gripping the handle 16 with the other handto manipulate the uterus.

The uterine manipulator portion 18 can include a substantially rigidprong 34 for insertion through the cervix into the uterus, a tenaculum(or a tenaculum clip) 36 with a sharp point for securing the uterinemanipulator to the cervix, and an anchoring member 44 having a pair ofwings 38 and 40 for anchoring the suspension member 20 to the vagina,can be coupled to the uterine manipulator 18. The wings 38 and 40 can beconstructed of a malleable, “shapememory” plastic, which allows for acomfortable fit into the vaginal fornices. Also, the wings 38 and 40 caneach include at least one, and in some embodiments, a plurality ofapertures 42 therein so that the practitioner can connect or suture thesuspension member 20 to the vagina through the apertures. The wings 38and 40 spread into the lateral corners of the vagina so that thesuspension member 20 can be secured to the vagina.

In one embodiment, a method of performing a vaginal uterine suspensionbegins by administering anesthesia to the patient. For example, either ageneral anesthesia or an epidural anesthesia can be used. A practitionermakes an anterior or posterior vaginal incision, performs a standardanterior colporrhaphy dissection, and palpates the ischial spinesbilaterally, all of which are generally well known to those skilled inthe art. As the uterine suspension device 10 is inserted into thevagina, the practitioner inserts the suspension member 20 through theanterior (or posterior) vaginal incision. The ends of the suspensionmember 20, i.e., the sutures 26 and 28, are anchored in a pelvic muscleor ligament such that the suspension member generally surrounds theuterus. In some embodiments, the first suture 28 with anchor 32 isanchored into the sacrospinous ligament or the levator muscle (such asthe iliococcygeus muscle) and the second suture 26 with anchor 30 isanchored into the sacrospinous or levator muscle on the opposite side,as depicted in FIG. 3. For example, the Capio® device manufactured byBoston Scientific can be used to place the sutures, although thoseskilled in the art will understand that various other suturing devicesand techniques can be employed as well, including using a needle trocarto perforate the muscle or ligament and anchor the suture, or attach thesuspension device 20 directly to the muscle. For example, the suspensiondevice 20 can be formed with a mesh material that can be anchoreddirectly to the tissue or muscle. Some iterations may involve fixationof mesh arms with no sutures/knot tying, by passing tension-freeself-affixing mesh through the tissue or muscle.

The prong 34 of the uterine manipulator 18 is inserted through thecervix into the uterus and is fastened thereto with the tenaculum clip36. In so doing, the wings 38 and 40 coupled to the device 10 arepositioned into the lateral corners of the vaginal apex. The suspensionmember 20 is fastened to the corners of the vaginal apex by suturing thesuspension member 20 to the inside of the vagina through the apertures42 in the wings 38 and 40. For example, sutures can be placed 2 cmlateral to the midline on each side. Optionally, the practitioner canuse bioabsorbable anchors or sutures to secure the suspension member 20to the vagina. Also optionally, if an augmentation is planned, ananterior or posterior graft can be secured with the same anchors at thevaginal apical corners.

The practitioner applies gentle traction on the sutures 26 and 28 (i.e.,pulling the sutures rearwardly from the device 10) while simultaneouslyslowly advancing the uterine manipulator 18 in a direction generallytowards the anchoring site e.g., the sacrospinous ligament or theiliococcygeus muscle). In so doing, the cervix along with the uterus ispushed up while the suspension member 20 shortens because of itsaccordion design and recreates the cardinaluterosacral attachmentsbetween the vaginal apex and the pelvic sidewall. The practitionerremoves the device 10, withdrawing it over the sutures 26 and 28, whichare held at constant tension. The practitioner ties the sutures 26 and28, without tension, leaving them inside the vaginal incision. Thevagina is closed after completion of anterior compartment repair (i.e.colporrhaphy, graft placement).

FIG. 4 illustrates a method according to an embodiment of the invention.A method includes at 50 repositioning a uterus of a patient into anormal anatomic position. At 52, the uterus is supported in the normalanatomic position with a uterine suspension member secured to a vaginalapex of the patient. In some embodiments, the repositioning of theuterus includes at 54, advancing a uterine manipulator in a directiontoward a selected portion of a pelvic tissue such that at least aportion of the uterus is moved upward. In some embodiments, the uterinesuspension member is positioned across the vaginal apex and an end ofthe uterine suspension member is anchored or secured to a portion ofpelvic tissue, and the uterine suspension member is also secured to thevaginal apex, at 56. In some embodiments, a first end of the uterinesuspension member is secured to a first portion of pelvic tissue and asecond end of the uterine suspension member is secured to a secondportion of pelvic tissue, at 58. In some embodiments, an end of theuterine suspension member is secured to a sacrospinous ligament. In someembodiments, the uterine suspension member is positioned around theuterus and secured to a levator muscle.

FIG. 5 illustrates a method according to another embodiment of theinvention. A method includes at 60 inserting at least a portion of auterine suspension member through an anterior or posterior vaginalincision. An end of the suspension member is anchored to a selectedportion of a pelvic tissue at 62. The pelvic tissue can be, for example,a sacrospinous ligament, or a levator muscle, such as an iliococcygeusmuscle. In some embodiments, the anchoring an end of the suspensionmember includes anchoring an end of a suture coupled to the suspensionmember to the selected portion of the pelvic tissue.

At 64, at least a portion of the suspension member is attached to avaginal apex. In some embodiments, the attaching the at least a portionof the suspension member to the vaginal apex includes at 66, coupling ananchoring member disposed within an interior of the vagina to thesuspension member such that a portion of a wall of the vagina isdisposed between the suspension member and the anchoring member. [n someembodiments, the attaching at least a portion of the suspension memberto the vaginal apex includes attaching the suspension member at a firstcorner of the vaginal apex and attaching the suspension member at asecond corner of the vaginal apex. In some embodiments, the suspensionmember has a first end and a second end, and the second end of thesuspension member is anchored to a second selected portion of a pelvictissue on an opposite side of the uterus at 68.

At 70, a uterine manipulator can be optionally advanced in a directiontoward the selected portion of tissue such that at least a portion of auterus is moved upward. At 72, in some embodiments, simultaneously withthe advancing the uterine manipulator, traction is applied to a suturecoupled to the suspension member.

In some embodiments, a kit can be provided that includes at least onesuspension member, such as suspension member 20, and a medical device,such as suspension device 10. The suspension member can have an endconfigured to be anchored to a pelvic tissue within a patient and aportion configured to be attached to a vaginal apex of the patient. Themedical device can be used during a uterine suspension procedure toassist in securing the suspension member within a pelvic region of thepatient. A kit can also include an anchoring member, such as anchoringmember 44, configured to be disposed within an interior of a vagina ofthe patient and coupleable to the suspension member to help secure thesuspension member to the vagina. A kit can also include at least onemesh or a graft to be used in a procedure such as a cystocele orrectocele augmentation.

CONCLUSION

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Thus, the breadth and scope of the inventionshould not be limited by any of the above-described embodiments, butshould be defined only in accordance with the following claims and theirequivalents.

The previous description of the embodiments is provided to enable anyperson skilled in the art to make or use the invention. While theinvention has been particularly shown and described with reference toembodiments thereof, it will be understood by those skilled in art thatvarious changes in form and details may be made therein withoutdeparting from the spirit and scope of the invention.

For example, a variety of different suspension members 20 can be used inany of the uterine suspension procedures described herein. A suspensionmember can be a variety of different configurations, shapes and/or sizesand be formed with various different materials not specificallydescribed. The suspension device 10 can include any combination orsubcombination of the various features and components described herein.Further, other configurations for a suspension device can be used toperform the uterine suspension procedures described herein, while stillremaining within the scope of the invention.

1. An apparatus, comprising: a suspension member having a middle portionsized and configured to be disposed across and secured to a vaginal apexand at least partially support a uterus of a patient; a first anchor forsecuring the suspension member to a portion of pelvic tissue on a firstside of the uterus; and a second anchor for securing the suspensionmember to a portion of pelvic tissue on a second opposite side of theuterus.
 2. The apparatus of claim 1, wherein the first anchor is coupledto a first suture, the second anchor is coupled to a second suture, thefirst and second sutures being interweaved within the suspension member.3. The apparatus of claim 1, wherein the first anchor is coupled to afirst suture, the second anchor is coupled to a second suture, the firstand second sutures being configured to support at least a portion of theuterus.
 4. The apparatus of claim 1, wherein the first anchor is coupledto a first suture, the second anchor is coupled to a second suture, thefirst and second sutures being configured to move the mesh into a foldedconfiguration upon application of traction on the sutures.
 5. Theapparatus of claim 1, further comprising: an anchoring member configuredto be disposed within an interior of a vagina and coupled to thesuspension member such that at least a portion of a wall of the vaginais between the anchoring member and the suspension member.
 6. Theapparatus of claim 1, wherein the suspension member is at leastpartially formed with a mesh material.
 7. The apparatus of claim 1,wherein the suspension member is configured to generally surround theuterus.
 8. The apparatus of claim 1, wherein the suspension member isconfigured to generally surround the uterus, a portion of the suspensionmember is configured to be disposed between a front of the patient andthe uterus of the patient.
 9. The apparatus of claim 1, wherein aportion of the suspension member is configured to be disposed between afront of the patient and the uterus of the patient.
 10. The apparatus ofclaim 1, wherein the suspension member is configured to form a “U” shapeto generally surround the uterus of the patient.
 11. A method,comprising: inserting at least a portion of a uterine suspension memberthrough an anterior vaginal incision of a patient; positioning theuterine suspension member such that the uterine suspension member formsa “U” shape and generally surrounds a uterus of the patient; anchoringan end of the suspension member to a selected portion of a pelvictissue; and securing at least a portion of the suspension member to avaginal apex.
 12. The method of claim 11, further comprising: advancinga uterine manipulator in a direction toward the selected portion of thepelvic tissue such that at least a portion of a uterus is moved upward.13. The method of claim 11, wherein the end of the suspension member isa first end, the selected portion of a pelvic tissue is a first selectedportion of a pelvic tissue, the method further comprising: prior to thesecuring, anchoring a second end of the suspension member to a secondselected portion of a pelvic tissue on an opposite side of a uterus. 14.The method of claim 11, wherein the securing the at least a portion ofthe suspension member to the vaginal apex includes coupling an anchoringmember disposed within an interior of the vagina to the suspensionmember such that a portion of a wall of the vagina is disposed betweenthe suspension member and the anchoring member.
 15. The method of claim11, wherein the securing the at least a portion of the suspension memberto the vaginal apex, includes securing the suspension member at a firstcorner of the vaginal apex and securing the suspension member at asecond corner of the vaginal apex.
 16. The method of claim 11, whereinthe anchoring an end of the suspension member includes disposing ananchor coupled to the suspension member to the selected portion of thepelvic tissue.
 17. The method of claim 11, wherein the anchoring an endof the suspension member includes disposing an end of a suture coupledto the suspension member to the selected portion of the pelvic tissue,the method further comprising: advancing a uterine manipulator in adirection toward the selected portion of the pelvic tissue such that atleast a portion of a uterus is moved upward; and simultaneously with theadvancing the uterine manipulator, applying traction to the suture. 18.An apparatus, comprising: a body having a proximal end and a distal end,the proximal end of the body configured to be inserted into a vagina ofa patient to assist in securing a uterine suspension member within apelvic region of the patient, the body defining a lumen and a firstopening on the distal end of the body and a second opening on theproximal end of the body, the first and second opening being incommunication with the lumen, the lumen configured to receive a suturecoupled to a suspension member that is disposed within a pelvic regionof the patient through the second opening such that an end of the sutureis disposed through the first opening and accessible outside the lumen;and a uterine manipulator disposed at the proximal end of the body, theuterine manipulator configured to be releasably coupled to a cervix ofthe patient during a uterine suspension procedure.
 19. The apparatus ofclaim 18, wherein the uterine manipulator includes a prong for insertionthrough the cervix and into a uterus of the patient, and a clip forsecuring the uterine manipulator to the cervix.
 20. The apparatus ofclaim 18, wherein the body is configured to releasably couple ananchoring member at the proximal end of the body such that the anchoringmember can be released from the body at a location within an interior ofthe vagina to help secure a uterine suspension member to the vagina.